Features:
- Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations
- Discusses worldwide regulatory requirements for filing for approval of generic drugs
- Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification
- Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects
- Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations
- Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies
Click here to view the book
